Dts-3000

FDA UDI

Class I (US FDA UDI)

by Daesung Maref Co., Ltd.

Identity

Trade Name: DTS-3000 FDA UDI
Generic Name: Surgical pneumatic tourniquet system FDA UDI
Device Name: Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea, DTC-CD1855 1ea), Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor FDA UDI
Model / Reference: DTSW410-SS-2 FDA UDI
Description: Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea, DTC-CD1855 1ea), Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 08809802644236 FDA UDI
FDA Product Code: KCY FDA UDI
GMDN Term: Surgical pneumatic tourniquet system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.5910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical pneumatic tourniquet system

Dts-3000 by Daesung Maref Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical pneumatic tourniquet system.

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A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
Zimmer Tourniquet — RENU MEDICAL, INC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Daesung Maref Co., Ltd.

Sources (1)

FDA UDI 6611eb9f-ada0-4389-a0e0-563f5bd7c1fd 33 fields · synced May 31, 2026